Last updated: 11/03/2018 11:27:49
Randomised, double-blind, placebo-controlled study of topical Clobetasone Butyrate 0.05% Cream in subjects with eczema for two weeks to evaluate the efficacy and safety
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Randomised, double-blind, placebo-controlled study of topical Clobetasone Butyrate Cream in patients with eczema for two weeks to evaluate the efficacy and safety
Trial description: This was a multicenter, randomised, double-blind, two treatment arms, vehicle (cream base) -controlled, parallel-group study in subjects with moderate to severe eczema (defined by investigators global assessment (IGA) score greater than or equal to 3). Subjects were screened within 3 days prior to randomization. At the screen visit, subjects gave informed consent and were then assessed for health status and eligibility for inclusion in the study. At the baseline visit, subject eligibility was assessed for randomization (Day 0). Eligible subjects were randomised to Clobetasone Butyrate 0.05% Cream group or vehicle (cream base) group at the rate of 1:1. During the treatment phase, subjects returned to the sites in day 7 post-baseline visit for assessment of their disease status and eligibility to continue on the study. During the final visit, 14 days after the baseline, subjects returned to the study sites for assessment of their disease status before completing the study. In addition, the safety and tolerability of Clobetasone Butyrate 0.05% cream were also assessed through the whole trial.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from baseline in Eczema Area and Severity Index (EASI) score at Day 7
Timeframe: Baseline, Day 7
Change from baseline in Eczema Area and Severity Index (EASI) score at Day 14
Timeframe: Baseline, Day 14
Reduction Percentage of Eczema Area and Severity Index (EASI) score after 7 day of treatment
Timeframe: up to Day 7
Reduction Percentage of Eczema Area and Severity Index (EASI) score after 14 days of treatment
Timeframe: up to Day 14
Secondary outcomes:
Change from baseline in Investigators Global Assessment (IGA) graded score at Day 7 and Day 14
Timeframe: Baseline, Day 7 and Day 14
Changes from baseline in Visual Analog Scale (VAS) at Day 7 and Day 14
Timeframe: Baseline, Day 7 and Day 14
Number of participants with participants-based assessment score of disease control at Day 7 and Day 14
Timeframe: Day 7 and Day 14
Interventions:
Drug: Clobetasone Butyrate 0.05% Cream
Drug: Vehicle (base cream)
Enrollment:
240
Observational study model:
Not applicable
Primary completion date:
2009-10-02
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Eczema
Product
clobetasone
Collaborators
Not applicable
Study date(s)
February 2008 to February 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12 - 65 years
Accepts healthy volunteers
No
- Subjects with a diagnosis of eczema, fulfil the 3 follow items: 1) Erythema, papilla/water blister, Lichenification, skin damage with infiltration, 2) unknown reason, recurrent attacks; 3) itching in diseased skin
- Subjects must have body surface area (BSA) disease involvement of less than or equal to 10% as assessed by palm method
- The subject presents with any systemic disorder or active skin disease (e.g. psoriasis) that would in any way confound interpretation of the study results or subjects who present with scars, moles, tattoos, body piercings, sunburn in the test area which could interfere with the assessment of lesions at screening.
- The subject has eczema restricted to the face, the feet or the hands only.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects with a diagnosis of eczema, fulfil the 3 follow items: 1) Erythema, papilla/water blister, Lichenification, skin damage with infiltration, 2) unknown reason, recurrent attacks; 3) itching in diseased skin
- Subjects must have body surface area (BSA) disease involvement of less than or equal to 10% as assessed by palm method
- Subject must present with moderate and above eczema as defined by a score greater than or equal to 3 using the investigators global assessment (IGA) of eczema severity.
Exclusion criteria:
- The subject presents with any systemic disorder or active skin disease (e.g. psoriasis) that would in any way confound interpretation of the study results or subjects who present with scars, moles, tattoos, body piercings, sunburn in the test area which could interfere with the assessment of lesions at screening.
- The subject has eczema restricted to the face, the feet or the hands only.
- The subject is indicated any anti-infectives drug for a current complication of overt bacterial, fungal and viral infection
- History of recent (<1 month) active or presence of current superficial skin infections of viral aetiology such as herpes simplex, or varicella.
- The subject has been exposed to below therapy within the set timeframe: Topical agents administered in the diseased skin, including emollient
- 1 week; Systemic administration of anti-histamine agents
- 2 week; Systemic administration of corticosteroid -4 week; Systemic administration of immunosuppressive drugs
- 4 week; UV therapy -4 week
- Foreseeable intensive ultraviolet (UV) exposure during the study (solar or artificial). Subjects must not be exposed to intense direct sunlight for long periods, and must not use skin tanning devices (e.g. sunbed) for the duration of the study.
- History of clinically significant cardiovascular, pulmonary, gastrointestinal, liver, neurological, renal or haematological abnormalities.
- History of allergy to components of test medications to be used in the study.
- History of anaphylaxis (a sudden, potentially life-threatening systemic allergic reaction) to food, medications, insect venom, or latex.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-10-02
Actual study completion date
2009-10-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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